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Pharmaceutical Patents › CAFC › Amgen

Haug Partners LLP

Federal Circuit Affirms Presumption of Separateness in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al., C.A....

Haug Partners LLP on

In a formulation claim, if elements are listed separately, does this necessarily entail that those elements are “separate and distinct components”?  This was the question before the district court in Regeneron...more

Proskauer - The Patent Playbook

The Supreme Court Kept the Door Open to Genus Claims

Proskauer - The Patent Playbook on

The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained...more

Foley & Lardner LLP

Can FDA Implement The BPCIA As The CAFC Suggested?

Foley & Lardner LLP on

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Goodwin

Breaking News: CAFC Affirms in Amgen v. Apotex

Goodwin on

The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning. The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A)...more

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